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The instrument amends the National Health
(Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to
make changes to the pharmaceutical benefits listed on the Pharmaceutical
Benefits Scheme (PBS).
PB 71 of 2012 determines the pharmaceutical benefits that
are on the Schedule of Pharmaceutical Benefits (the PBS Schedule) through
declarations of drugs and medicinal preparations, and determinations of
forms, manners of administration and brands. The price of items listed in PB
71 of 2012 is subsidised by the Commonwealth.
The instrument provides for the addition of the listed
drugs pegcetacoplan and vericiguat, and forms of the listed drugs
amoxicillin, amoxicillin with clavulanic acid, and oxybutynin to the PBS
Schedule. It also provides for the deletion of the listed drug prednisolone
acetate, and for the deletion of forms of the listed drugs abatacept,
fluconazole, nitrofurantoin, and primidone. Moreover, the instrument alters
the circumstances in which a prescription may be written for the supply of
the listed drugs abatacept, adalimumab, baricitinib, certolizumab pegol,
escitalopram, etanercept, evolocumab, golimumab, infliximab, lanadelumab,
leuprorelin, lorlatinib, natalizumab, pembrolizumab, somatropin, tofacitinib,
and upadacitinib.
Schedule 1 to the instrument also provides for the
following changes:
- the
addition of 12 brands of existing pharmaceutical items
- the
deletion of seven brands of existing pharmaceutical items
- the
deletion of a pack quantity for one existing pharmaceutical item
- the
alteration of responsible persons code for two existing brands of
pharmaceutical item
- the
deletion of one responsible person from the list of responsible persons
- the
addition of 12 existing pharmaceutical items covered under Supply Only
arrangements
- the
deletion of two pharmaceutical items covered under Supply Only arrangements.
See the Explanatory
Statement for the instrument for further information.
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Registered on Federal Register of Legislation: 30
November 2022 [F2022L01546]
Tabled in House of Representatives: 1 December
2022
Tabled in Senate: not yet tabled
Disallowance period (sitting days): 15 days
Administered by: Health and Aged Care
Commencement: 1 December 2022
Made under: sections
84AF, 84AK,
85,
85A,
88
and 101
of the National
Health Act 1953
Regulation Impact Statement: none identified
Committee comment: none identified
Commentary: none identified
Resources:
- ‘About the PBS’,
Department of Health and Aged Care.
- ‘Pharmaceutical
Benefits Scheme’, Services Australia.
- Rebecca
Storen, Rosalind Hewett and Emma Vines, The
Pharmaceutical Benefits Scheme: a quick guide, Research paper series,
2021–22, (Canberra: Parliamentary Library, 2022).
- ‘Adalimumab’,
Versus Arthritis.
- ‘Amoxicillin
- Uses, Side Effects, and More’, WebMD.
- ‘Baricitinib’,
Versus Arthritis.
- ‘Certolizumab
Pegol’, Versus Arthritis.
- ‘Empaveli
(Pegcetacoplan)’, Therapeutic Goods Administration.
- ‘Escitalopram
Oxalate - Uses, Side Effects, and More’, WebMD.
- ‘Etanercept’,
Versus Arthritis.
- ‘Evolocumab’,
NPS MedicineWise, 1 October 2016.
- ‘Fluconazole
(Oral Route)’, Mayo Clinic.
- ‘Golimumab’, Versus Arthritis.
- ‘Infliximab
(Intravenous Route)’, Mayo Clinic.
- ‘Lanadelumab
for hereditary angioedema’, NPS MedicineWise, 4 March 2022.
- ‘Leuprorelin
acetate’, NPS MedicineWise, 1 March 2004.
- ‘Lorlatinib
for non-small cell lung cancer’, NPS MedicineWise, 22 October 2020.
- ‘Natalizumab’,
NPS MedicineWise, 1 August 2007.
- ‘Nitrofurantoin
Capsule - Uses, Side Effects, and More’, WebMD.
- ‘Oxybutynin
(Oral Route)’, Mayo Clinic.
- ‘Pembrolizumab
(Keytruda)’, Cancer Research UK.
- ‘Prednisolone
Acetate Suspension, Drops (Final Dose Form) - Uses, Side Effects, and More’,
WebMD.
- ‘Primidone
(Oral Route)’, Mayo Clinic.
- ‘Somatropin
5 Mg (15 Unit) Solution For Injection - Uses, Side Effects, and More’,
Web MD.
- ‘Tofacitinib’,
Therapeutic Goods Administration, 15 October 2019.
- ‘Upadacitinib
for rheumatoid arthritis’, NPS MedicineWise, 6 August 2020.
- ‘Verquvo (Vericiguat)’,
Therapeutic Goods Administration.
- ‘What
is abatacept?’, Versus Arthritis.
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